Parenteral and sterile products are usually required to be sterile at the time of injection into or application to the human body. Pharmaceutical manufacturers of Sterile Products must follow a plethora of regulations and current Good Manufacturing Processes such as: 21 CFR 210; 21CFR 211; 21 CFR 11; USP <797>; CGAMP; GLP; GCP; Cleaning Validations; WHO Requirements; Re-Validation Requirements, just to name a few. For parenteral and sterile products, these regulations have a few objectives in common: TO INSURE THAT THE FINISHED PRODUCT IS SAFE FOR HUMAN USE; THAT IT IS EFFECTIVE: and, if it is a sterile product, THAT IT REMAINS STERILE UNTIL ADMINISTRATION TO A HUMAN or ANIMAL.
As professionals, the doctors, nurses, pharmacists, dentists, veterinarians and others who administer injections should maintain the sterility of the product through purchase to administration to a patient.
However, in a multitude of cases, this is not so. Examining the average pharmacy one should be able to observe some, if not most, of the following when an injection is prepared, opened and administered to the next customer or patient in line. The common factors of contamination are, but not limited to: dirt, dust, food, paperwork, contaminated prescriptions, exposed trash, etc. on lab surface; dirt, stains, dust on floors, rug and walls; air vents laden with dust and mold just blowing down on the injection; the professional to administer the injection has exposed hair, hands, nails and lab coat all contributing to contamination; the sink area with filth, rust, sponges, equipment not cleaned and water which may not be fit to drink; direct access to outside in pharmacies with drive-through; customers and patients coughing, spitting, sneezing, blowing their noses, touching and contaminating the areas where the injection is to be compounded, prepared and administered. If the FDA would enter a sterile drug manufacturer with these infractions of cGMPs ongoing, they would certainly issue an FDA483 or FDA Warning Letter. The manufacturing site, may even be shut down and all products produced recalled.
It is just not Pharmacy at fault, many of the same conditions and worse can be found in Doctor's Offices, Clinics, Hospitals, various stores, gas stations, and other places of vaccine administration. It is sad that the professional worries about getting the vaccine or injection into the patient but doesn't care about the handling and contamination of the sterile drug at the time of preparation and administration to the patient.
By contrast, this invention keeps the injection in an aseptic environment During preparation and all the way through administration to the patient.